CompletedPhase 1

A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling

United States14 participantsStarted 2023-07-10

Plain-language summary

The purpose of this clinical trial is to learn about the pharmacokinetics and safety of a drug called zavegepant from samples collected using a patient-centric device called Tasso-Plus (for liquid blood sample collection) and Tasso-M20 (for dried blood sample collection) compared to standard venous sample collection. This study consists of two periods and will enroll approximately 14 healthy participants. In period 1, half of the enrolled participants (n=7) will use Tasso-Plus, and the other 50% (n=7) will use Tasso-M20. For each participant, PK samples will be collected after zavegepant administration in period 1 using the assigned Tasso device simultaneously with collecting venous blood samples. In addition, taste assessments will be performed at time intervals of 1 (immediately after dosing), 5, 10 and 20 minutes after zavegepant IN administration. Also, if feasible, 4 Japanese participants will be enrolled among those 14 participants to evaluate the PK and safety of zavegepant IN in Japanese vs. non Japanese participants. In period 2, a butterscotch candy will be given 5 minutes before administering the zavegepant IN study intervention. Taste assessment will also be performed after zavegepant IN administration with a butterscotch candy in period 2. For taste assessment, each participant will record the sensory attributes at timed intervals of 1 (immediately after dosing), 5, 10 and 20 minutes after zavegepant administration in each period. The expected duration of participation from screening until follow-up telephone contact is approximately 9 weeks.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female ≥18 years of age and older at the time of signing the informed consent document (ICD).
✓. Male and female participants who are overtly healthy as determined by medical evaluation.
✓. Body Mass Index (BMI) 16.0-32.0 kg/m2 and body weight ≥45.0 kg (99 lb).
✓. Females must not be breastfeeding or lactating and must have a negative urine or serum pregnancy test (minimum sensitivity 25 international units per liter \[IU/L\] or equivalent units of human chorionic gonadotropin \[HCG\]) at screening. Woman/women of childbearing potential (WOCBP) must have negative urine or serum pregnancy test at admission.

Exclusion criteria

✕. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
✕. Clinically significant history of nasal conditions that may affect the administration or absorption of the nasal product (eg, severe septum deviation or nasal deformity, inflammation, perforation, mucosal erosion, localized infection or ulceration, congestion, polyposis, rhinorrhea, nasal surgery within the previous 6 months, or nasal trauma).

What they're measuring

Plasma Concentration of Zavegepant at 30 Minutes Post-dose on Day 1 of Period 1- Tasso Device Versus (vs.) Standard Venous Phlebotomy

Timeframe: 30 minutes post-dose on Day 1 of Period 1

Plasma Concentration of Zavegepant at 1 Hour Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

Timeframe: 1-hour post-dose on Day 1 of Period 1

Plasma Concentration of Zavegepant at 2 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

Timeframe: 2-hours post-dose on Day 1 of Period 1

Plasma Concentration of Zavegepant at 4 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

Timeframe: 4-hours post-dose on Day 1 of Period 1

Plasma Concentration of Zavegepant at 8 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

Timeframe: 8-hours post-dose on Day 1 of Period 1

Plasma Concentration of Zavegepant at 12 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

Timeframe: 12-hours post-dose on Day 1 of Period 1

Area Under the Plasma Concentration-Time Profile From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Zavegepant: - Tasso Device vs. Standard Venous Phlebotomy

Trial details

NCT IDNCT05948085

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-05

Results submitted2024-08-28

View on ClinicalTrials.gov More Healthy trials